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PhoenixSM
has been successfully working with clients in the pharmaceutical,
food, and medical device industries for many years. Here are
a few of our success stories with the client's names omitted
to ensure confidentiality.
Success Story #1: As part of Phoenix's ongoing electronic
submission service, we submitted the first electronic food
additive petition to FDA. This service
expedited FDA's review of the submission.
Success Story #2: We have assisted four major drug/biologic
companies that received consent decrees. As
a result, the companies were allowed to continue marketing
their products.
Success Story #3: We have worked with many clients
assisting in the preparation of premarket submissions to
all FDA centers, including combination products involving
more than one center. Our
assistance has lightened our clients' internal workload and
helped bring their products to market.
Success Story #4: We have advised clients in the preparation
of responses to FDA's 483s and Warning Letters. These
efforts have resulted in positive FDA responses, assuring
continued marketing of the clients' products and preventing
enforcement actions.
Success Story #5: We have routinely conducted CGMP/QSR/GCP/GLP
audits to include mock FDA PAI audits for NDA approval. For
example, Phoenix recently conducted PAI audits at five sites
in Japan. The client implemented our recommended corrective
action which facilitated the sites meeting NDA requirements.
The NDAs were
approved.
Success Story #6: We have served as an effective independent
auditor of medical device firms that have been placed on integrity
hold. Our services
have helped these firms respond to FDA concerns.
Success Story #7: Phoenix
has conducted GCP audits for numerous
clients and assisted them with corrective actions. The
result: Successful FDA Bioresearch inspections!
Success Story #8: Phoenix
has provided regulatory advice to US drug companies on adapting their
development and registration plans to accommodate EU requirements, including
setting up and managing meetings with EMEA and MHRA. Our
European regulatory insight and assistance has facilitated global marketing
of our US clients' products.
Success Story #9: In Japan, we serve as a valuable resource for the
Japanese pharmaceutical industry. Using the presentation, “Points for
Successful FDA Inspection,” we have provided Japanese pharmaceutical
companies with important facts in how to manage a successful FDA inspection.
This presentation has also been published in a well-known Japanese magazine.
Our consulting services have facilitated many successful
PAI inspections for Japanese companies.
Success Story #10: Our Japanese Associate has published several
articles in the Pharm Tech Japan, Vol. 20 (2004), including the
following: “Fundamentals of FDA Inspection,” “Persons
Receiving Investigators,” “How to Deal with Investigators,”
and “General Affairs and Concrete Points to be Considered.”
These articles have provided the Japanese pharmaceutical
industry with many helpful facts about the USFDA inspection
procedures.
Announcements
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Articles
Want More Information on Successful Risk Management for
Your Device and Diagnostics Company?
Please see the article, Expert Advises Companies on Successful Risk Management, from FDA News Device & Diagnostics Letter, featuring Phoenix's Charma Konnor, R.Ph., RAC, Senior Manager/Consultant, Devices and Drugs.
Reprinted with permission, FDANews © 2005. FDANews. All Rights Reserved. www.fdanews.com
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